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High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS T...
Medical Devices·19,884 affected·Apr 15, 2016
High RiskFDA
Covidien Llc
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 ...
Diagnostic Devices·12,895 affected·Apr 15, 2016
High RiskFDA
Ziehm Imaging Inc
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
Medical Devices·14 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement...
Surgical Devices·148,334 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physician...
Surgical Devices·60,302 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic p...
Surgical Devices·532,395 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MON...
Medical Devices·19,884 affected·Apr 15, 2016
High RiskFDA
Carestream Health Inc
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 65...
Medical Devices·37 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the ut...
Medical Devices·1,881 affected·Apr 15, 2016
High RiskFDA
Ziehm Imaging Inc
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
Medical Devices·2 affected·Apr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB...
Medical Devices·19,884 affected·Apr 15, 2016
High RiskFDA
Covidien Llc
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-031...
Diagnostic Devices·1,305 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
B. Braun Medical, Inc.
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inve...
Medical Devices·11,000 affected·Apr 14, 2016
High RiskFDA
Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibril...
Cardiac Devices·17 affected·Apr 14, 2016
High RiskFDA
Randox Laboratories, Limited
Magnesium on RX Imola analyser IVD
Medical Devices·15 affected·Apr 14, 2016
High RiskFDA
Biosense Webster, Inc.
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pent...
Cardiac Devices·13,912 affected·Apr 14, 2016
High RiskFDA
Biosense Webster, Inc.
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster ...
Cardiac Devices·59,672 affected·Apr 14, 2016
High RiskFDA
Mary's Homemade
Mary's Home Made Vegetable Soup; 16 FL. OZ. (1 Pint) OR 32 FL. OZ. (1 Quart); Heat and Serve
Produce·12 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-L...
Diagnostic Devices·54,351 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination ...
Diagnostic Devices·43,877 affected·Apr 13, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, ...
Medical Devices·30 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipas...
Diagnostic Devices·32,926 affected·Apr 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (...
Medical Devices·8 affected·Apr 13, 2016
High RiskFDA
Baxter Healthcare Corp.
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufac...
Injectable Drugs·11,630 affected·Apr 12, 2016
High RiskFDA
Stanmore Implants Worldwide Ltd.
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Medical Implants·1 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip ...
Medical Devices·1 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total...
Medical Devices·2 affected·Apr 12, 2016
High RiskFDA
Stryker Corporation
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) an...
Medical Implants·3,100 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total h...
Medical Devices·1 affected·Apr 12, 2016
High RiskFDA
Milky Way Intl Trading Corp
Mixed Fruit (In Light Syrup), Net Wt. 8oz (227g), Bottle Label UPC 0-49022-80896-6, Case UPC 100-49022-80896-3
Produce·838 affected·Apr 11, 2016
High RiskFDA
Qtrade Teas And Herb
Organic Chamomile Tea Bag Cut (TBC) bulk sold in original cases (25kg bags), Bulk product 25 kg craft paper bags "L 0609-13681-238641-...
Beverages·1,267 affected·Apr 11, 2016
High RiskFDA
Echopixel, Inc.
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health c...
Medical Devices·9 affected·Apr 11, 2016
High RiskFDA
Biomet, Inc.
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Medical Devices·22 affected·Apr 11, 2016
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040...
Medical Devices·13,541 affected·Apr 11, 2016
High RiskFDA
Ethicon, Inc.
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an...
Surgical Devices·228 affected·Apr 11, 2016
High RiskFDA
Ion Beam Applications S.a.
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Medical Devices·2 affected·Apr 11, 2016
High RiskFDA
Bindi North America
Bindi Amerana Cherry Grana Gelato 1.24 Gal Container (4.8L) UPC 815073016588
Food·3 affected·Apr 8, 2016
High RiskFDA
Bindi North America
Bindi USA Chocolate Gelato 1.24 Gal Container (4.8 L) UPC 815073016564
Snacks & Candy·177 affected·Apr 8, 2016
High RiskFDA
Bindi North America
Bindi USA Vanilla Bean Gelato 1.24 Gal Container (4.8 L) UPC 815073016557
Food·373 affected·Apr 8, 2016
High RiskFDA
Dmh Ingredients Inc
Organic Lemon Myrtle packed in a 12.5kg plastic bag inside of a cardboard box.
Food·20 affected·Apr 8, 2016
High RiskFDA
Bindi North America
Bindi Cappucino Gelato 1.24 Gal Container (4.8L) UPC 815073016595
Food·165 affected·Apr 8, 2016
High RiskFDA
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information man...
Diagnostic Devices·28 affected·Apr 8, 2016